Phase 3 Study With Ciprofloxacin Dispersion for Inhalatio... | NCT02104245

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2014Actual

Primary Completion Date

Aug 11, 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 8, 2018

Certification/Extension First Submitted that Passed QC Review

Jan 8, 2018

Certification/Extension First Posted Date

Jan 10, 2018Actual

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 26, 2021Actual

Name	Class
Grifols Therapeutics LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ciprofloxacin dispersion for inhalation	Experimental	Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin	Drug: Ciprofloxacin dispersion for inhalation
Placebo	Placebo Comparator	Liquid formulation of empty liposomes	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin dispersion for inhalation	Drug		Ciprofloxacin dispersion for inhalation
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first pulmonary exacerbation (from baseline)		48 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of non-CF bronchiectasis
History of P. aeruginosa respiratory infections
At least two pulmonary exacerbations treated with antibiotics in the previous year

Exclusion Criteria:

Have a clinical diagnosis of CF
Are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32554534	Derived	Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.
30658914

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena